EP1219316B1 - Method of forming a laryngeal mask assembly - Google Patents

Method of forming a laryngeal mask assembly Download PDF

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Publication number
EP1219316B1
EP1219316B1 EP01309645A EP01309645A EP1219316B1 EP 1219316 B1 EP1219316 B1 EP 1219316B1 EP 01309645 A EP01309645 A EP 01309645A EP 01309645 A EP01309645 A EP 01309645A EP 1219316 B1 EP1219316 B1 EP 1219316B1
Authority
EP
European Patent Office
Prior art keywords
mount
tube
cuff
forming
laryngeal mask
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP01309645A
Other languages
German (de)
French (fr)
Other versions
EP1219316A2 (en
EP1219316A3 (en
Inventor
Michael Norman Collins
Eric Pagan
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Smiths Group PLC
Original Assignee
Smiths Group PLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Smiths Group PLC filed Critical Smiths Group PLC
Publication of EP1219316A2 publication Critical patent/EP1219316A2/en
Publication of EP1219316A3 publication Critical patent/EP1219316A3/en
Application granted granted Critical
Publication of EP1219316B1 publication Critical patent/EP1219316B1/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0402—Special features for tracheal tubes not otherwise provided for
    • A61M16/0409—Special features for tracheal tubes not otherwise provided for with mean for closing the oesophagus

Definitions

  • This invention relates to methods of forming laryngeal mask assemblies.
  • airway known as a laryngeal mask for administering anaesthetic and ventilation gases to a patient.
  • These airways comprise a tube with an inflatable mask or cuff at one end, the tube being inserted in the patient's mouth so that one end is located in the hypopharynx and so that the mask forms a seal in this region with the surrounding tissue.
  • Laryngeal masks are described in, for example, US 5355879 , US 5305743 , US 5297547 , US 5282464 , GB 2267034 , US 5249571 , US 5241956 , US 5303697 , GB 2249959 , GB 2111394 , EP 448878 , US 4995388 , GB 2205499 , GB 2128561 , GB 2298797 , GB 2334215 , GB2337020 , PCT/GB00/03044 , PCT/GB00/03045 , GB 0002805 and GB 0020274 .
  • Laryngeal masks usually comprise a curved, extruded tube, a separate mount member joined at the patient end of the tube and an inflatable cuff attached to the mount member.
  • WO 00/61213 describes a laryngeal mask where the tube and mount member are made together by rotational moulding.
  • Laryngeal masks have several advantages over endotracheal tubes, which are longer and seal with the trachea below the vocal folds.
  • the multiple components and assembly operations needed to make the masks add to their cost.
  • a method of forming a laryngeal mask assembly including the steps of moulding a first integral component comprising a tube and a mount with the mount at the patient end of the tube, forming a second component in the form of an inflatable annular sealing cuff entirely of a thin, flexible, inflatable plastics material and having a circular transverse section throughout, and attaching the thin, flexible, inflatable, circular section of the cuff directly with the mount so that the cuff extends around the patient end of the mount.
  • the sealing cuff may be attached with the mount by an adhesive.
  • the tube and mount are preferably moulded together by injection moulding and may be moulded of polyurethane
  • a laryngeal mask assembly according to the present invention will now be described, by way of example, with reference to the accompanying drawing, which is a side elevation view of the assembly.
  • the laryngeal mask assembly comprises a tube 1 and a mask formation 2 at the patient end 10 of the tube.
  • the tube 1 is of a bendable plastics material, such as PVC and is curved along its length.
  • a bore 11 extends along the tube from its patient end 10 to its rear, machine end 12.
  • the mask 2 comprises a mount 20 and an inflatable sealing cuff 21.
  • the mount 20 is of a relatively stiff plastics material and is of generally shoe shape.
  • the mount 20 and tube 1 are moulded together, such as by injection moulding, to form an integral, single piece 22.
  • the mount 20 tapers outwardly from its machine end 23 to its patient end 24, which is inclined to the axis of the machine end at an angle of about 25° so that the patient end of the mount has an oval shape with its forward end 25 being more pointed than its rear end 26.
  • the patient end 24 of the mount 20 is inclined to face towards the inner side of the curve of the tube 1.
  • the mount 20 has a cavity 27 that increases in cross-sectional area along its length, from the machine end.
  • the cuff 21 is tubular and of a thin flexible plastics material.
  • the cuff 21 is formed into an annulus of the same shape as the patient end 24 of the mount 20 so that it is oval with its forwardly-directed end 30 being more pointed than its rearwardly-directed end 31.
  • the cuff 21 encloses a central region 32 of the same shape as the patient end 24 of the mount 20.
  • the cuff 21 is attached around the patient end 24 of the mount 20 such as by means of an adhesive.
  • the cuff 21 is inflated and deflated by means of an inflation line 40 which is provided by a separate small-bore tube communicating with the interior of the cuff and extending rearwardly along a groove 41 in the outside of the tube. When inflated in position in a patient, the cuff 21 expands to contact patient tissue in the region of the hypopharnyx.
  • the mount and tube are formed in one operation, there are fewer separate components and fewer steps needed to manufacture the assembly.
  • By avoiding the need to bond the mount to the tube there is no risk of a faulty bond and there is no need to inspect a bond.
  • Moulding the tube and mount together enables the wall thickness or shape to be varied, if desired, at different points along the length of the tube. It is also possible, by moulding, to use different materials, such as polyurethane, which present problems with extrusion.

Description

  • This invention relates to methods of forming laryngeal mask assemblies.
  • It is common practice to use an airway known as a laryngeal mask for administering anaesthetic and ventilation gases to a patient. These airways comprise a tube with an inflatable mask or cuff at one end, the tube being inserted in the patient's mouth so that one end is located in the hypopharynx and so that the mask forms a seal in this region with the surrounding tissue. Laryngeal masks are described in, for example, US 5355879 , US 5305743 , US 5297547 , US 5282464 , GB 2267034 , US 5249571 , US 5241956 , US 5303697 , GB 2249959 , GB 2111394 , EP 448878 , US 4995388 , GB 2205499 , GB 2128561 , GB 2298797 , GB 2334215 , GB2337020 , PCT/GB00/03044 , PCT/GB00/03045 , GB 0002805 and GB 0020274 . Laryngeal masks usually comprise a curved, extruded tube, a separate mount member joined at the patient end of the tube and an inflatable cuff attached to the mount member. WO 00/61213 describes a laryngeal mask where the tube and mount member are made together by rotational moulding.
  • Laryngeal masks have several advantages over endotracheal tubes, which are longer and seal with the trachea below the vocal folds. The multiple components and assembly operations needed to make the masks, however, add to their cost.
  • It is an object of the present invention to provide an alternative method of forming a laryngeal mask assembly.
  • According to the present invention there is provided a method of forming a laryngeal mask assembly including the steps of moulding a first integral component comprising a tube and a mount with the mount at the patient end of the tube, forming a second component in the form of an inflatable annular sealing cuff entirely of a thin, flexible, inflatable plastics material and having a circular transverse section throughout, and attaching the thin, flexible, inflatable, circular section of the cuff directly with the mount so that the cuff extends around the patient end of the mount.
  • The sealing cuff may be attached with the mount by an adhesive. The tube and mount are preferably moulded together by injection moulding and may be moulded of polyurethane
  • A laryngeal mask assembly according to the present invention will now be described, by way of example, with reference to the accompanying drawing, which is a side elevation view of the assembly.
  • The laryngeal mask assembly comprises a tube 1 and a mask formation 2 at the patient end 10 of the tube.
  • The tube 1 is of a bendable plastics material, such as PVC and is curved along its length. A bore 11 extends along the tube from its patient end 10 to its rear, machine end 12.
  • The mask 2 comprises a mount 20 and an inflatable sealing cuff 21. The mount 20 is of a relatively stiff plastics material and is of generally shoe shape. The mount 20 and tube 1 are moulded together, such as by injection moulding, to form an integral, single piece 22. The mount 20 tapers outwardly from its machine end 23 to its patient end 24, which is inclined to the axis of the machine end at an angle of about 25° so that the patient end of the mount has an oval shape with its forward end 25 being more pointed than its rear end 26. The patient end 24 of the mount 20 is inclined to face towards the inner side of the curve of the tube 1. Internally, the mount 20 has a cavity 27 that increases in cross-sectional area along its length, from the machine end.
  • The cuff 21 is tubular and of a thin flexible plastics material. The cuff 21 is formed into an annulus of the same shape as the patient end 24 of the mount 20 so that it is oval with its forwardly-directed end 30 being more pointed than its rearwardly-directed end 31. The cuff 21 encloses a central region 32 of the same shape as the patient end 24 of the mount 20. The cuff 21 is attached around the patient end 24 of the mount 20 such as by means of an adhesive. The cuff 21 is inflated and deflated by means of an inflation line 40 which is provided by a separate small-bore tube communicating with the interior of the cuff and extending rearwardly along a groove 41 in the outside of the tube. When inflated in position in a patient, the cuff 21 expands to contact patient tissue in the region of the hypopharnyx.
  • Because the mount and tube are formed in one operation, there are fewer separate components and fewer steps needed to manufacture the assembly. By avoiding the need to bond the mount to the tube, there is no risk of a faulty bond and there is no need to inspect a bond. It is possible to achieve a smooth external profile in the region between the tube and mount, without a step or bump, because there is no connection in this region. Moulding the tube and mount together enables the wall thickness or shape to be varied, if desired, at different points along the length of the tube. It is also possible, by moulding, to use different materials, such as polyurethane, which present problems with extrusion.

Claims (4)

  1. A method of forming a laryngeal mask assembly including the steps of moulding a first integral component comprising a tube (1) and a mount (20) with the mount at the patient end of the tube, forming a second component in the form of an inflatable annular sealing cuff (21) entirely of a thin, flexible, inflatable plastics material, characterized by attaching the thin, flexible, inflatable, circular section of the cuff (21) directly with the mount (20) so that the cuff extends around the patient end of the mount, and by that said cuff (21) has a circular transverse section throughout.
  2. A method of forming a laryngeal mask assembly according to Claim 1, characterised in that the sealing cuff (21) is attached with the mount (20) by an adhesive.
  3. A method according to Claim 1 or 2, characterised in that the tube (1) and mount (20) are moulded together by injection moulding.
  4. A method of forming a laryngeal mask assembly according to any one of the preceding claims, characterised in that the tube (1) and mount (20) are moulded of polyurethane.
EP01309645A 2000-12-22 2001-11-15 Method of forming a laryngeal mask assembly Expired - Lifetime EP1219316B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0031661 2000-12-22
GBGB0031661.2A GB0031661D0 (en) 2000-12-22 2000-12-22 Laryngeal mask assemblies

Publications (3)

Publication Number Publication Date
EP1219316A2 EP1219316A2 (en) 2002-07-03
EP1219316A3 EP1219316A3 (en) 2004-01-02
EP1219316B1 true EP1219316B1 (en) 2007-07-04

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP01309645A Expired - Lifetime EP1219316B1 (en) 2000-12-22 2001-11-15 Method of forming a laryngeal mask assembly

Country Status (7)

Country Link
US (2) US20020078961A1 (en)
EP (1) EP1219316B1 (en)
JP (1) JP4629934B2 (en)
AU (1) AU780207B2 (en)
CA (1) CA2363893A1 (en)
DE (1) DE60129198T2 (en)
GB (2) GB0031661D0 (en)

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EP1613384B1 (en) * 2003-04-11 2014-06-04 Ambu A/S Laryngeal mask and method for the manufacture thereof
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GB0510951D0 (en) 2005-05-27 2005-07-06 Laryngeal Mask Company The Ltd Laryngeal mask airway device
GB2444779A (en) 2006-12-14 2008-06-18 Archibald Ian Jeremy Brain A laryngeal mask with with drug delivery means
GB0810169D0 (en) * 2008-06-04 2008-07-09 Cosmeplast Ets Improvements relating to respiratory interface devices
GB0903654D0 (en) 2009-03-03 2009-04-15 Laryngeal Mask Company The Ltd Artificial airway device
KR20120070559A (en) 2009-07-06 2012-06-29 우메데이스 리미티드 Artificial airway
USD665495S1 (en) 2009-07-14 2012-08-14 Muhammed Aslam Nasir Medical device
CN102498377B (en) 2009-08-13 2014-05-14 奇姆德恩医疗有限公司 Pressure indicator
GB201010647D0 (en) 2010-06-24 2010-08-11 Docsinnovent Ltd Stopper device
GB201016562D0 (en) 2010-10-01 2010-11-17 Laryngeal Mask Company The Ltd Artificial airway device
AU2011315319B2 (en) 2010-10-15 2016-06-02 Teleflex Life Sciences Llc Artificial airway device
USD688787S1 (en) 2011-06-08 2013-08-27 Intersurgical Ag Airway device cap and strap holder
USD693920S1 (en) 2011-06-08 2013-11-19 Intersurgical Ag Airway device
USD665254S1 (en) 2011-06-08 2012-08-14 Intersurgical Ag Airway device packaging
USD712244S1 (en) 2011-09-23 2014-09-02 Intersurgical Ag Medical device package
GB201120628D0 (en) 2011-11-30 2012-01-11 Laryngeal Mask Company The Ltd Endoscopy device
GB201201438D0 (en) 2012-01-27 2012-03-14 Docsinnovent Ltd Improved stopper device
USD761952S1 (en) 2012-07-27 2016-07-19 Docsinnovent Limited Airway device
CH706616A2 (en) * 2012-06-04 2013-12-13 Deltona Innovations Ag Laryngeal mask with a supraglottic tube.
GB2546167B (en) 2013-12-17 2018-02-28 Aslam Nasir Muhammed Intubating Airway Device
USD842456S1 (en) 2015-12-15 2019-03-05 Intersurgical Ag Airway device
AU201714823S (en) 2017-02-27 2017-10-12 Teleflex Life Sciences Unlimited Co Laryngeal mask airway device
GB201720733D0 (en) 2017-12-13 2018-01-24 Ashkal Development Ltd Airway device

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Also Published As

Publication number Publication date
EP1219316A2 (en) 2002-07-03
GB0031661D0 (en) 2001-02-07
US20020078961A1 (en) 2002-06-27
DE60129198T2 (en) 2007-11-08
DE60129198D1 (en) 2007-08-16
CA2363893A1 (en) 2002-06-22
EP1219316A3 (en) 2004-01-02
GB0127184D0 (en) 2002-01-02
JP2002200169A (en) 2002-07-16
JP4629934B2 (en) 2011-02-09
AU780207B2 (en) 2005-03-10
GB2371990A (en) 2002-08-14
GB2371990B (en) 2004-06-16
AU9515101A (en) 2002-06-27
US20050109345A1 (en) 2005-05-26

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